“Blood plasma” or “plasma” is the liquid component of blood, in which the blood cells are in suspension. It is possible to separate plasma from whole blood by centrifugation or filtration across a membrane. Blood plasma is constituted essentially by water, plasma proteins (mainly albumin and antibodies) and coagulation factors, including fibrinogen. Blood plasma is used in therapy for treating serious coagulopathies with collapse of all the coagulation factors and also for treating acute haemorrhages, with overall deficiency of the coagulation factors.
Currently, the therapeutic plasma generally used is fresh frozen plasma (FFP) originating from biologically qualified donations (immunohaematological tests, nucleic acid amplification detection of HIV, HCV and HBV viruses), which can be made safe vis-à-vis pathogens by quarantine or physico-chemical treatment. Such a plasma needs to be stored at a temperature less than or equal to −25° C., which means that it can only be administered after thawing under specific conditions. Furthermore, this type of plasma cannot be stored for more than a year, which leads to significant losses. Finally, this therapeutic plasma must be used with care since its administration must comply with the rules regarding delivery based on recipient ABO compatibilities. In addition to the use of compatible plasmas, iso-group plasma transfusion must therefore be preferred in order to avoid any risk of post-transfusion haemolysis due to ABO incompatibility.
Because of the restrictions linked to its use and to its storage and therefore its availability, such fresh frozen plasma proves unsuited to use under emergency conditions, in particular in a hospital environment or in a location outside a hospital environment (scenes of accidents or disasters, areas that are difficult to access, areas with restricted or non-existent access to cold chains, theatres of military operation).
A need therefore exists for a plasma corresponding to the constraints of the hospital and non-hospital environment, can be stored at ambient temperature, free of any form of bacterial, viral or parasitic contamination and compatible with any recipient, independently of their ABO blood group.
Application WO2012/022914 describes a process for obtaining a lyophilized plasma, originating from a mixture of plasma from selected donors and belonging exclusively to blood group AB or to blood groups A or B. The process described in application WO2012/022914 cannot be implemented with donors belonging to blood group O.
Application US20110008459 describes a universal plasma obtained by mixing the plasmas from donors of blood groups A and B and optionally AB to the exclusion of any plasma originating from donors of blood group O, in which the free anti-A and anti-B antibody titre is less than 16 for immunoglobulins M (IgM) and less than 64 for immunoglobulins G (IgG).